Cerebral oxygen saturation as an indicator of postoperative cardio-renal organ function and neurocognitive outcome in patients undergoing transcatheter aortic valve implantation.

• Conditions: Hemodynamic change and its outcome-relevant influence during transcatheter aortic valve implantation.; I35.0; Aortic (valve) stenosis

• Registration Number: DRKS00020813
• Lead Sponsor: Immanuel Klinikum Bernau, Herzzentrum Brandenburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-06-01
• Study Start: 2022-12-12
• Results First Posted: 2023-05-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

Elective transcatheter aortic valve implantation (TAVI).

No contraindication to neurocognitive testing

Ability to understand the scope and significance of the study

Written informed consent to participate in the study

Exclusion Criteria

Emergency intervention

Dialysis patients

Patient (or proxy) is unable to provide written informed consent to participate in the
give written informed consent for participation in the study

Diseases, due to which neurocognitive testing is not possible

Attending physician does not recommend participation in the study

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AKI incidence in patients above versus below median cerebral saturation (rSO2).

Secondary Outcome Measures

Name	Time	Method
- ? creatinine and ? NT-proBNP in patients* above versus below the median cerebral saturation (rSO2).<br>- Cumulative cerebral desaturation (AUC, maximum, minimum).<br>- Time [min] rSO2 <50% / frequency of episodes.<br>- Time to MAD/rSO2 recovery (+/-10% from baseline) after RVP.<br>- Changes in cognitive tests